Respiratory Distress Syndrome in Premature InfantPhase 4NCT06554522
Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa
A Phase 4 study testing Surfactant in people with Respiratory Distress Syndrome in Premature Infant and RDS of Prematurity, run by Indiana University at 8 sites in 4 countries.
Trial summary
The goal of this pragmatic clinical trial is to learn if the drug surfactant given by a less invasive technique works to treat respiratory distress in preterm infants in low- and middle-income African countries where invasive ventilators are unavailable. Read more about this study
- Who is it for?
- Ages 1 hour to 24 hours
- Conditions the study is for
- Respiratory Distress Syndrome in Premature Infant, RDS of Prematurity, Surfactant Deficiency Syndrome Neonatal
- What is being tested?
- Surfactant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,512 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 1 Jan 2025to 30 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight between 750 and 2000 grams or gestational age between 24- and 35 weeks.
- Silverman Anderson Score ≥5 before or after CPAP treatment.
- Admitted to a study site within 24 hours of life.
Who cannot join
- Major congenital or genetic anomalies.
- Active pulmonary hemorrhage.
- Major craniofacial anomalies that preclude the successful use of CPAP
Trial locations and contacts
8 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 4 countries
Ghana3 sites, 3 recruiting
- Not yet recruiting
Korle-Bu Teaching Hospital
Accra
Sally O Manu, MD, sal.omanu83@gmail.com
- Not yet recruiting
Komfo Anokye Teaching Hospital
Kumasi
Naana A. Wireko Brobby, MD, mayiwah@yahoo.com
- Not yet recruiting
Tamale Teaching Hospital
Tamale
Alhassan Abdul-Mumin, MD MS, +233546439573, amumuni14@yahoo.co.uk
Kenya2 sites, 2 recruiting
- Not yet recruiting
Coast General Teaching & Referral Hospital
Mombasa
Nayirat Mohamed, MD, nayiratdor@gmail.com
- Not yet recruiting
Mama Lucy Kibaki Hospital
Nairobi
Justus M Simba, MD, jsimba@jkuat.ac.ke
Nigeria2 sites, 2 recruiting
- Recruiting
Federal Teaching Hospital Ido-Ekiti
Ido-Ekiti, Ekiti State
Samuel Ajigbotosho, MBBS, samajigbotosho@gmail.com
- Recruiting
University of Ilorin Teaching Hospital
Ilorin, Kwara State
Oluwabunmi Mokuolu, MBBS, oluwabunmiabogunrin@yahoo.com
Central African Republic1 site, 1 recruiting
- Not yet recruiting
Centre Hospitalier Universitaire Communautaire
Bangui
Cynthia N Ningatoloum, MD, cynthinaz@yahoo.fr
About this study
Official title: Pragmatic Evaluation of Therapies to Enhance Respiratory Management in Preterm Infants in Africa
The goal of this pragmatic clinical trial is to learn if the drug surfactant given by a less invasive technique works to treat respiratory distress in preterm infants in low- and middle-income African countries where invasive ventilators are unavailable. It will also learn about the safety of the less invasive surfactant administration (LISA) technique. The main questions it aims to answer are:
Does surfactant given by a less invasive surfactant administration technique improve survival in preterm infants in low- and middle-income countries? What medical problems do participants have when receiving surfactant given by the less invasive surfactant administration technique?
Read more
Researchers will implement the less invasive surfactant administration technique and see if it works to treat respiratory distress in preterm infants compared to preterm who did not receive surfactant.
Participants with respiratory distress who are being treated with continuous positive airway pressure and caffeine citrate will:
Receive surfactant replacement therapy by the less invasive surfactant administration technique.
Be monitored for complications Be followed throughout their hospitalization to determine their survival rate.
Read the detailed description
The low- and middle-income countries of Sub-Saharan Africa (SSA) carry the highest burden of preterm births and deaths. A primary driver of preterm mortality in SSA is respiratory distress syndrome. Surfactant replacement therapy by the less invasive surfactant administration (LISA) is a technique where the surfactant is administered to a preterm neonate with respiratory distress syndrome managed on continuous positive airway pressure (CPAP), reducing the need for using an invasive mechanical ventilator. In high-income countries, LISA has been shown to be effective in reducing the need for invasive mechanical ventilators and mortality. However, the impact of LISA is unknown in low-resourced settings without ventilators.
The central hypothesis is that implementing LISA in newborn units that care for preterm neonates using standardized CPAP and caffeine citrate will improve survival in preterm neonates.
PICO Outline:
Population: Preterm neonates 750 and 2000 grams or gestational age between 24- and 35 weeks at birth with respiratory distress defined by a Silverman Anderson Score of ≥5, who are spontaneously breathing and on CPAP.
Intervention: Surfactant administered through the less invasive surfactant administration (LISA), technique.
Comparator: Standard of care - standardized CPAP and Caffeine.
Outcome measures: Primary Outcome: All-cause in-hospital survival.
- Conditions
- Respiratory Distress Syndrome in Premature Infant, RDS of Prematurity, Surfactant Deficiency Syndrome Neonatal, Premature Birth
- Being tested
- Surfactant
- Medical subject headings
- Respiratory Distress Syndrome In Premature Infants, Pulmonary Atelectasis, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurfactantDrug
Also called Less Invasive Surfactant Administration Technique
Surfactant is instilled into the lungs through a thin catheter passed into the trachea during laryngoscopy while on continuous positive airway pressure (CPAP)
| Study group | Role | What they receive |
|---|---|---|
| Non-LISA Group | No intervention | Preterm infants with respiratory distress syndrome who are on continuous positive airway pressure support and being treated with caffeine citrate. |
| LISA Group | Experimental | Preterm infants with respiratory distress syndrome, who are on continuous positive airway pressure support are treated with caffeine citrate and surfactant through the less invasive surfactant administration technique. Receives: Drug: Surfactant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Survival
Survival to hospital discharge
Measured: Through hospitalization, an average of 6 months
Secondary outcomes (3)
Incidence of major preterm neonatal morbidity
Intraventricular hemorrhage, Retinopathy of Prematurity, Bronchopulmonary Dysplasia, Surgical Necrotizing Enterocolitis and Culture Positive Sepsis
Measured: Through hospitalization, an average of 6 months
The incidence of pneumothorax
Air leaks into the space between your lung and chest wall
Measured: Through hospitalization, an average of 6 months
Hospital survival at seven day
Survival rates assessed at day seven of life
Measured: 7 days following birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start1 Jan 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome in Premature InfantStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A stepped wedge cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 1,512 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Coefficient Giving
- Responsible party
- Principal investigator, Osayame Ekhaguere, Indiana University
- Investigators
- Osayame A Ekhaguere, MBBS, MPH, Principal investigator, Indiana UniversityHelen Nabwera, BMedSci, Principal investigator, Aga Khan UniversityOlufunke Bolaji, MBBS, Principal investigator, Afe Babalola UniversityEdgardo Szyld, MD, MS, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554522
- Sponsor's protocol ID
- 22326
- Status last verified
- Mar 2026
- First submitted
- 12 Aug 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest. The data shared will be coded, with no personal health information included. Approval of the request and execution of all applicable agreements (e.g., a material transfer agreement) are prerequisites to sharing data with the requesting party.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Evaluation of Therapies to Enhance Respiratory Management in Preterm Infants in Africa
- ClinicalTrials.gov ID
- NCT06554522
- Acronym / sponsor ID
- 22326
- Conditions
- Respiratory Distress Syndrome in Premature Infant, RDS of Prematurity, Surfactant Deficiency Syndrome Neonatal, Premature Birth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,512 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Coefficient Giving
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pragmatic clinical trial is to learn if the drug surfactant given by a less invasive technique works to treat respiratory distress in preterm infants in low- and middle-income African countries where invasive ventilators are unavailable. It will also learn about the safety of the less invasive surfactant administration (LISA) technique. The main questions it aims to answer are:
Does surfactant given by a less invasive surfactant administration technique improve survival in preterm infants in low- and middle-income countries? What medical problems do participants have when receiving surfactant given by the less invasive surfactant administration technique?
Researchers will implement the less invasive surfactant administration technique and see if it works to treat respiratory distress in preterm infants compared to preterm who did not receive surfactant.
Participants with respiratory distress who are being treated with continuous positive airway pressure and caffeine citrate will:
Receive surfactant replacement therapy by the less invasive surfactant administration technique.
Be monitored for complications Be followed throughout their hospitalization to determine their survival rate.
Detailed description
The low- and middle-income countries of Sub-Saharan Africa (SSA) carry the highest burden of preterm births and deaths. A primary driver of preterm mortality in SSA is respiratory distress syndrome. Surfactant replacement therapy by the less invasive surfactant administration (LISA) is a technique where the surfactant is administered to a preterm neonate with respiratory distress syndrome managed on continuous positive airway pressure (CPAP), reducing the need for using an invasive mechanical ventilator. In high-income countries, LISA has been shown to be effective in reducing the need for invasive mechanical ventilators and mortality. However, the impact of LISA is unknown in low-resourced settings without ventilators.
The central hypothesis is that implementing LISA in newborn units that care for preterm neonates using standardized CPAP and caffeine citrate will improve survival in preterm neonates.
PICO Outline:
Population: Preterm neonates 750 and 2000 grams or gestational age between 24- and 35 weeks at birth with respiratory distress defined by a Silverman Anderson Score of ≥5, who are spontaneously breathing and on CPAP.
Intervention: Surfactant administered through the less invasive surfactant administration (LISA), technique.
Comparator: Standard of care - standardized CPAP and Caffeine.
Outcome measures: Primary Outcome: All-cause in-hospital survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A stepped wedge cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Non-LISA Group | No intervention | –Preterm infants with respiratory distress syndrome who are on continuous positive airway pressure support and being treated with caffeine citrate. |
| LISA Group | Experimental | Drug: SurfactantPreterm infants with respiratory distress syndrome, who are on continuous positive airway pressure support are treated with caffeine citrate and surfactant through the less invasive surfactant administration technique. |
Who may qualify
- Ages
- 1 hour to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Birth weight between 750 and 2000 grams or gestational age between 24- and 35 weeks.
- Silverman Anderson Score ≥5 before or after CPAP treatment.
- Admitted to a study site within 24 hours of life.
Key exclusion criteria (3 listed)
- Major congenital or genetic anomalies.
- Active pulmonary hemorrhage.
- Major craniofacial anomalies that preclude the successful use of CPAP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurfactantAlso: Less Invasive Surfactant Administration TechniqueSurfactant is instilled into the lungs through a thin catheter passed into the trachea during laryngoscopy while on continuous positive airway pressure (CPAP) | Drug | LISA Group |
Primary outcome
Hospital Survival
Time frame: Through hospitalization, an average of 6 months
Survival to hospital discharge
3 secondary outcomes
Incidence of major preterm neonatal morbidity
Time frame: Through hospitalization, an average of 6 months
The incidence of pneumothorax
Time frame: Through hospitalization, an average of 6 months
Hospital survival at seven day
Time frame: 7 days following birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest. The data shared will be coded, with no personal health information included. Approval of the request and execution of all applicable agreements (e.g., a material transfer agreement) are prerequisites to sharing data with the requesting party.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Osayame A Ekhaguere, MBBS, MPH principal investigator
Indiana University
Helen Nabwera, BMedSci principal investigator
Aga Khan University
Olufunke Bolaji, MBBS principal investigator
Afe Babalola University
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Surfactant in people with Respiratory Distress Syndrome in Premature Infant and RDS of Prematurity, run by Indiana University at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Ghana, Kenya, Nigeria, Central African Republic. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Osayame A Ekhaguere (+13179443691, osaekhag@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Survival (time frame: Through hospitalization, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.